Oxidative Stress in Motor Neuron Disease: COSMOS Add-On Study
Completed
Conditions studied: Motor Neuron Disease, Primary Lateral Sclerosis
In brief
Background: \- Primary lateral sclerosis (PLS) is a disorder in which nerve cells in the brain that control movement degenerate. The cause of PLS is not known, but some research has suggested that environmental factors that produce oxidative stress trigger PLS in people who carry certain genes. Oxidative stress is caused when the body makes chemicals called "free radicals" faster than its natural systems can break them down. Oxidative stress can be triggered by exposures to chemicals related to the bodily effects of lead, smoking, alcohol consumption, physical activity, and psychological stress. Chemicals produced by the body during oxidative stress can be measured in the blood and urine. Researchers are interested in studying the physical, neurological, and chemical effects of PLS to better understand the effects of oxidative stress on the disorder. Objectives: \- To study the relation of oxidative stress to the diagnosis and progression of motor neuron disease. Eligibility: \- Individuals 20 years of age or older who have been diagnosed with PLS, and have had symptoms of PLS for at least 5 but not more than 8 years and been previously enrolled in 01-N-0145 Screening: Neurologic Disorders with Muscle Stiffness Design: * Participants will have an initial study visit and three follow-up visits. Each visit will require approximately 3 days of testing at the National Institutes of Health Clinical Center. * As part of this study, participants will have the following tests and procedures: * Neurological examination to test muscle strength, sensation, coordination, and reflexes, as well as clarity of speech * Tests of memory, attention, concentration, and thinking * Surveys on oxidative stress, including questions on life, mood, jobs held, and habit * Electromyography to record the electrical activity of muscles * Transcranial magnetic stimulation to measure electrical activity translated from their brain to the muscles * Blood, urine, and skin biopsy samples for testing and sample collection * After the initial visit, participants will have three more visits, once each in the following 3 years.
Key facts
- Study ID
- NCT01143428
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 10
- Starts
- 2010-05-13
- Expected to finish
- 2015-08-03
- Last updated by the study team
- 2019-11-05
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients will be excluded if they:
- Have EMG evidence of active denervation or fasciculations in more than a few muscles with chronic neurogenic motor unit potentials at the time of enrollment
- Have only lower extremity involvement
- Have major medical diseases (e.g. active cancer, dialysis) that have required active medical treatment within the past 6 months
- Are participating in clinical treatment trials at the time of enrollment and acquisition of baseline biological samples (participation in clinical trials after the baseline visit is permitted)
- Are unwilling or unable to return for follow-up visits
- Have pacemakers or other implanted electrical devices, which might make TMS unsafe will be excluded from TMS testing
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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